MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREW INSERTER T8 SELF-RETAINING/QC; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Model Number	03.617.904
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: there was no known reported patient involvement associated with the complained event.Unknown when device malfunctioned.(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested and is currently pending completion.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 during an inspection of field equipment on (b)(6) 2018, it was noted that two (2) screw inserters were stripped.Although devices used in the past by various hospital accounts the device malfunctions were noted outside of any hospital and it was confirmed that no patient or surgical procedure was impacted.(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.Additional narrative: date device received at manufacturing site for investigation.A device history record (dhr) review was performed for part no.: 03.617.904, lot no.: 9875954, manufacturing location: haegendorf, release to warehouse date: 05.Apr.2016: no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.A product investigation was performed.The screw inserter (part 03.617.904, lot 9875954, mfg 05.Apr.2016) was received at us cq with a stripped distal tip.The complaint condition was visually confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the devices were returned damaged.The complaint condition is confirmed as the driver (part 03.617.904, lot 9875954) was received stripped.A device inspection, device history record review and drawing review were performed as part of this investigation.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces (such as being over torqued).No new malfunctions were observed during the course of this investigation.Based on the investigation findings, 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: SCREW INSERTER T8 SELF-RETAINING/QC
• Common Device Name: APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7335834
• Report Number: 2939274-2018-51040
• Device Sequence Number: 218493
• Product Code: KWQ
• UDI-Device Identifier: 10705034717180
• UDI-Public: (01)10705034717180(10)9875954
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K152239
• 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
• Report Date (Section B): 02/13/2018

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: 03.617.904
• Device Catalogue Number: 03.617.904
• Device Lot Number: 9875954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1