MAUDE Adverse Event Report: SYNTHES GMBH 13.0MM/10.0MM PROTECTION SLV F/4.5MM TI MULTILOC SCR/150MM; GUIDE

Catalog Number	03.019.013
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2021, the patient underwent the surgery with the protection sleeves in question.During the surgery, the surgeon had a difficulty inserting the protection sleeves into b hole of the aiming arm (03.019.008), and it took a long time to reach the bone.The surgeon also had a difficulty removing the protection sleeves too.The surgery was completed successfully.No further information is available.Concomitant medical products: unk - guides/sleeves/aiming: aiming arm a(part# unknown, lot# unknown, qty unk) this complaint involves one (1) device.This report is for (1)13.0mm/10.0mm protection slv f/4.5mm ti multiloc scr/150mm.This report is 1 of 2 of (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.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.H3, h6: a product investigation was conducted.The product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that protect sleeve 13/10 l150 no visual issues were identified.The dimensional inspection was not performed due to alleged complaint condition.Functional test cannot be performed since the device was received by itself.The observed condition of protect sleeve 13/10 l150 in the device was not consistent with the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for protect sleeve 13/10 l150.While no definitive root cause could be determined, there is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H3, h6: a device history record (dhr) review was conducted: part: 03.019.013 lot: 9793763 manufacturing site: hagendorf release to warehouse date: 12 february 2016 a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 13.0MM/10.0MM PROTECTION SLV F/4.5MM TI MULTILOC SCR/150MM
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12650874
• Report Number: 8030965-2021-08761
• Device Sequence Number: 19196140
• Product Code: FZX
• UDI-Device Identifier: 07611819427136
• UDI-Public: 07611819427136
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2021

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: 03.019.013
• Device Lot Number: 9793763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2016
• 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: AIM-ARM LAT F/MULTILOC PHN
• Patient Sex: Unknown