MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PELVIC ARM 225MM; FORCEPS

Model Number	398.752
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history records has been requested.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
It was reported on an unknown date, the hohmann style arm has a sliding mechanism stuck to it.It is unknown when the issue was observed.Procedure and patient outcome were unknown.This complaint involves two (2) devices.This report is for one (1) sliding mechanism.This report is 2 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.A device history record (dhr) review was conducted: part: 398.753.Lot: 14-8596.Manufacturing site: selzach.Supplier: leitner ag.Release to warehouse date: 30.May 2014.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A product investigation was conducted.Visual inspection: visual inspection of the returned pelvic arm revealed deep circular scratches/gouges to the interior surface (inner diameter) of the housing component's 16mm hole.No other damage was noted to the device.Functional test: the sliding mechanism was not returned to cq; therefore functional testing could not be performed.Functional testing of both devices was performed at synthes service and repair (s&r).The devices were able to be separated during s&r evaluation.Dimensional inspection: the inner diameter of the 16mm hole measured, which was out of specification of 16mm per relevant drawing.Although a functional test could not be performed by cq and s&r did not experience a functional issue, the damaged hole, which was out of specification, could contribute to the complaint condition.Therefore, the complaint is considered confirmed with investigation.Document/specification review: the relevant drawing(s) was reviewed; no design issues were observed.Conclusion: the complaint condition is confirmed.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.A root cause could not be determined, however, the device may have been damaged during improper use and handling.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.
Event or Problem Description
This report is for one (1) pelvic arm 225m.
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.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Part number correction - 398.752, reported on initial mwr-03042019-0000392598, correct part #398.753.Udi reported on initial (b)(4), correct udi: (b)(4).Service & repair evaluation:that were inadvertently added to follow-up mwr-07052019-0000427304.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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.: it was reported that the hohmann style arm has a sliding mechanism stuck to it.The item passed testing per the inspection sheet and worked within normal parameters.The complained issue was not able to be reproduced.The cause of the complained issue is unknown.The item passed synthes final inspection on 08-april-2019 and will be returned to the customer upon completion of the service and repair process.Attached service record router completed through operation 30.Finalized service record will be archived in tungsten document management system.The evaluation was unconfirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative 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.

• Brand Name: PELVIC ARM 225MM
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8529841
• Report Number: 2939274-2019-57554
• Device Sequence Number: 11230453
• Product Code: HTD
• UDI-Device Identifier: 10886982201560
• UDI-Public: (01)10886982201560
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/26/2019

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 Model Number: 398.752
• Device Catalogue Number: 398.753
• Device Lot Number: 14-8596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 04/10/2019; 05/10/2019; 05/13/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 05/08/2019; 05/10/2019; 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1