MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNFRAME LENGTHENER; LAMP, OPERATING ROOM

Model Number	387.338
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is synthes sales representative.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, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 that, on an unknown date, during an evaluation in the loaners department the synframe half ring and synframe lengthener were difficult to unscrew.Procedure and patient involvement is unknown.This report is for one (1) synframe lengthener.This is report 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.Dhr review was completed.Part: 387.338 , lot: l189850 , manufacturing site:hägendorf , release to warehouse date: 16 dec 2016.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process review of the device history record(s) showed that there were no issues during the manufacture of this product, which would contribute to this complaint condition customer quality conducted an investigation of the returned device.Us customer quality (cq) investigation flow: device interaction/functional.Visual inspection: visual inspection at cq of the returned synframe lengthener revealed stripping of the hex screw¿s drive recess.No damage was noted to the opposing flat-head screw¿s drive recess.No additional damage was noted to the remaining features/component.Functional test: due to the stripping, the hex screw could not be turned with an appropriate driver.Although the half ring was not returned to cq, assembly and disassembly with a half ring would presumably not be possible.The received condition agreed with the complaint condition.Conclusion: the complaint was confirmed during investigation.After a visual inspection per guidance provided in document, it is determined that the reusable instrument device is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During investigation, no product design or manufacturing issues were observed that may have contributed have contributed to the complaint condition; therefore, further corrective and/or preventative action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Date device returned to manufacturer.Reporter is synthes employee.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: SYNFRAME LENGTHENER
• Common Device Name: LAMP, OPERATING ROOM
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7974877
• Report Number: 2939274-2018-54434
• Device Sequence Number: 1739100
• Product Code: FQP
• UDI-Device Identifier: 10705034771076
• UDI-Public: (01)10705034771076
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K993314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2018

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: 387.338
• Device Catalogue Number: 387.338
• Device Lot Number: L189850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 11/05/2018; 11/28/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 11/05/2018; 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1