MAUDE Adverse Event Report: SYNTHES GMBH AIM-ARM F/PHILOS 3.5; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.122.007
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the philos aiming arm doesn't match the holes of the philos plate.There was a surgical delay of ten (10) minutes.A new instrument set was used.The procedure was successfully completed.There were no patient consequences.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 additional manufacturer narrative: h3, h6: part number: 03.122.007 lot number: 599p563 manufacturing site: hägendorf release to warehouse date: 01-feb-2022.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.The product was not returned to medtech orthopaedics; however, photos were provided for review.The investigation was not able to confirm the reported event as the complaint condition was not represented clearly in the provided photo.The provided evidence was not sufficient to confirm the reported event of inability to assemble/disassemble.Device interaction issues cannot be evaluated through a photo investigation.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the photographs provided are not representative of the reported complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: added: d9.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: corrected: g1.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.H3, h6: the product was not returned to medtech orthopaedics; however, photos were provided for review.The investigation was not able to confirm the reported event as the complaint condition was not represented clearly in the provided photo.The provided evidence was not sufficient to confirm the reported event of inability to assemble/disassemble.Device interaction issues cannot be evaluated through a photo investigation.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the photographs provided are not representative of the reported complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review: part number: 03.122.007.Lot number: 599p563.Manufacturing site: hägendorf.Release to warehouse date: 01-feb-2022.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: h3, h4, h6: the product was returned to j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there were no damage or defect with the aim-arm f/philos 3.5 a dimensional inspection for the aim-arm f/philos 3.5 was not performed as it is not applicable to the complaint condition.A functional test was performed with the mating devices insert-handle f/philos 3.5 w/connecscr h (part: 03.122.006), philos 3.5 3ho sst (part: 241.901) and outersleeve f/percutaneous lcp aiming in (part: 03.113.009), the aim-arm was able to connect with the mating components and the sleeve was aligned without problems to # 2 and 3 locking holes, laterals and central holes in both directions.The complaint condition was not able to be replicated.The overall complaint was not confirmed as the observed condition of the aim-arm f/philos 3.5 would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.There is no indication that a design or manufacturing issue has caused the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review (dhr): part number: 03.122.007.Lot number: 599p563.Manufacturing site: hägendorf.Release to warehouse date: 01-feb-2022.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: AIM-ARM F/PHILOS 3.5
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HAEGENDORF; im bifang 6; haegendorf CO ; SZ
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22641847
• Report Number: 8030965-2025-07641
• Device Sequence Number: 5267222
• Product Code: FZX
• UDI-Device Identifier: 07611819334458
• UDI-Public: (01)07611819334458(10)599P563
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.122.007
• Device Lot Number: 599P563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 08/13/2025; 09/02/2025; 09/04/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 08/14/2025; 09/03/2025; 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INSERT-HANDLE F/PHILOS 3.5 W/CONNECSCR H.; OUTERSLEEVE F/PERCUTANEOUS LCP AIMING IN.; PHILOS 3.5 3HO SST.
• Patient Sex: Unknown