MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STAGBEETLE FORCEPS 125MM; MISC ORTHO SURGICAL INSTRUMENT

Model Number	398.93
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation summary could not be completed; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.Items will not be returned.The customer will send to warranty department for a repair, 393.10 t-handle chuck 398.9.If additional information is made available, the investigation will be updated as applicable.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 july 19, 2019, the universal chuck with t-handle was bent and the tip of the bone spreader beak broke off during inspection.There was no patient involvement.This complaint involves two (2) devices.This report is for one (1) bone spreader 7 mm beak width this report is for 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.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.Investigation summary background: it was reported on (b)(6) 2019, the universal chuck with t-handle was bent and the tip of the bone spreader beak broke off during inspection.There was no patient involvement.This complaint involves two (2) devices.Investigation flow: damage.Visual inspection: the stagbeetle forceps 125 mm (p/n: 398.96, lot # t955386) was returned and received at us cq.Upon visual inspection, it was observed that the device was broken and the broken fragments were not returned to us cq.The etch on the device was faded.No other issues were identified with the returned components of the device.Dimensional inspection no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device and broken fragments not being returned.The device received is broken.Hence confirming the allegation.Investigation conclusion the complaint condition is confirmed for the stagbeetle forceps 125 mm (p/n: 398.96, lot # t955386) asn the returned device is broken and the broken fragments were not returned.There is no indication that a design or manufacturing issue has caused the breakage and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied on the device.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.A review of the device history record device history lot part number: 398.96, lot number: t955386, manufacturing site: tuttlingen, release to warehouse date: 01-dec-2010.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.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: STAGBEETLE FORCEPS 125MM
• Common Device Name: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8902786
• Report Number: 2939274-2019-59868
• Device Sequence Number: 13506954
• Product Code: LXH
• UDI-Device Identifier: 10886982201980
• UDI-Public: (01)10886982201980
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2019

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: 398.93
• Device Catalogue Number: 398.96
• Device Lot Number: T955386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 09/03/2019; 10/01/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 09/04/2019; 10/03/2019
• Patient Sequence Number: 1