MAUDE Adverse Event Report: SYNTHES GMBH PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 5.0MM SCREWS; GUIDE

Catalog Number	03.108.002
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Investigation summary: photo investigation: the device was not returned.A photo-investigation was performed on the images.Upon inspecting the images provided, the k-wire was observed to be jammed in the aiming block.The devices show nicks & scratches indicating signs of use.However, the root cause for the reported event cannot be determined from the available information.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition can be confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history review: a dhr review could not be performed as the device lot number is unknown.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.
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 aiming block was got stuck a needle with spade point one of the holes and make damage with dent.It was unknown what type of procedure performed.The patient outcome was unknown.This complaint involves one (1) device.This report is for (1)pediatric lcp hip plate guiding block for 5.0mm screws this report is 1 of 2 for (b)(4).
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.H6: the device was received, the investigation is in progress, 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6:.Part: 03.108.002.Lot: 4l97898.Manufacturing site: bettlach.Supplier: n/a.Release to warehouse date: july 8, 2019.Expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the aiming block f/scr ø5 f/lcp paed-hipp (part #: 03.108.002, lot #: 4l97898) (was returned to us customer quality cq.Upon visual inspection, the k wire was found stuck inside one of the holes of the aiming block.There were scratches on the device but have no impact on the device functionality.No other issues were identified with the returned device.Functional test: the k wire was jammed in the aiming hole of the aiming block.The wire did not budge during the functional test after many tries.Can the complaint condition be replicated? yes, the complaint condition can be replicated during the functional test.Dimensional inspection: a dimensional inspection was not performed since the k-wire was jammed in the hole, hence complaint relevant dimension could not be measured.Document/specification review: based on the date of manufacture, the current and manufactured version of the drawing for the part were reviewed.Complaint confirmed? yes.Conclusion: the complaint condition was confirmed as the k wire was stuck inside the aiming block.A definitive assignable root cause of this issue cannot be identified during the investigation.No product design issues or discrepancies were observed.No manufacturing issues were noted during the investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d4; d7a; d9; h4 h6: photo investigation: a photo-investigation was performed on the images provided.Upon inspecting the images provided, the k-wire was observed to be jammed in the aiming block.The devices show nicks & scratches indicating signs of use.However, the root cause for the reported event cannot be determined from the available information.Conclusion: the complaint condition can be confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.H3, h6: the subject device has been received, the investigation is in progress, 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.

• Brand Name: PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 5.0MM SCREWS
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12510119
• Report Number: 8030965-2021-07914
• Device Sequence Number: 14266729
• Product Code: FZX
• UDI-Device Identifier: 07611819847224
• UDI-Public: 7611819847224
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 08/24/2021

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: 03.108.002
• Device Lot Number: 4L97898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 10/13/2021; 11/10/2021; 11/10/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 11/07/2021; 11/10/2021; 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2019
• 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
• Patient Sex: Unknown