MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC EXTRACTION BOLT FOR 3.5MM & 4.0MM SCREWS; EXTRACTOR

Model Number	309.039
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
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.Reporter is a synthes employee.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.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 (b)(6) reports an event as follows: it was reported that on an unknown date, one (1) t-handle with quick coupling broke and won't detach the extraction bolt.It is unknown how the issue was discovered.It is unknown if there was patient involvement.This report is for a extraction bolt for 3.5mm & 4.0mm screws.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: updated data-h4 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.Release to warehouse date: 05.March 2018.A review of the device history record device history lot part: 309.039, lot: l675751, manufacturing site: bettlach, release to warehouse date: 05.March 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device history batch null, device history review = review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Investigation summary background: it was reported that on an unknown date, one (1) t-handle with quick coupling broke and won't detach to the extraction bolt.It is unknown how the issue was discovered.It is unknown if there was patient involvement.This complaint involves two (2) devices.Investigation flow: device interaction & damage.Visual inspection: the t-handle with quick coupling (part # 311.44 lot # 4602891) was received at us cq stuck to the extract-bolt f/scr ø3.5+4 (part # 309.039 lot # l675751).The distal tip of the extract-bolt was broken off, no fragments were returned to us cq.These findings are consistent with the reported complaint description.Functional test: a functional test was performed, the device was not able to be disassembled at us cq.The t-handle would not disengage from the extraction bolt.The reported complaint was replicated thus confirming the complaint condition.Dimensional inspection: dimensional inspection could not be performed because the distal tip of the device completely broken off.The coupling could also not be measured because it remains stuck in the t-handle.Because of these issues, there was no access to measure relevant features.Document/specification review: drawing(s) reviewed: (current & manufactured revisions).No design issues were identified with the reviewed drawings.Manufacturing record evaluation: the extract-bolt f/scr ø3.5+4 (part # 309.039 lot # l675751) was manufactured at the bettlach site on 05-mar-2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Conclusion: the complaint condition is confirmed as the t-handle with quick coupling was received with extract-bolt f/scr ø3.5+4 (part # 309.039 lot # l675751) stuck in the quick coupling and unable to be released.The distal tip of the extraction bolt was clearly broken off.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.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.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: EXTRACTION BOLT FOR 3.5MM & 4.0MM SCREWS
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8752800
• Report Number: 2939274-2019-58962
• Device Sequence Number: 16561136
• Product Code: HWB
• UDI-Device Identifier: 10886982185563
• UDI-Public: (01)10886982185563
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2019

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: 309.039
• Device Catalogue Number: 309.039
• Device Lot Number: L675751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 07/10/2019; 08/06/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 08/05/2019; 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1