MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BONE SPREADER 7MM BEAK WIDTH; MISC ORTHO SURGICAL INSTR

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 expected to be returned for manufacturer review/investigation, but has yet to be received.Occupation: reporter is synthes sales consultant.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
It was reported that during a routine inspection on an unknown date, while cleaning in sterile processing department (spd), the bone spreader came out broken.There was no procedure and patient involvement.This report is for one (1) bone spreader.This is report 1 of 1 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.H3, h6: part: 398.93; synthes lot: t149123; release to warehouse date: september 26, 2017; manufacture site: tuttlingen; part expiration date: n/a; list of nonconformances: n/a.A review of the device history records (dhr) showed that there were no issues at the time of manufacturing of this device and its sub components that would contribute to the complaint condition.The raw material certificate was reviewed, and the used material was according to the specification of the device.No nonconformance reports (ncrs) were generated during the production of this device.Review of the device history record of tuttlingen showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.Visual inspection: visual inspection performed at customer quality identified that the device was received with broken spindle.Hence, the complaint condition is confirmed.The rest of the broken part of the spindle, speed nut and end cap were not received.The received condition agrees with the complaint description.There is no clear indication that the complaint condition occurred due to misuse.Document review: bone spreader dimensional analysis: dimensional inspection was not able to be performed on the relevant portions as the broken portions were not returned.Dhr and raw material review: a review of the device history records showed that there were no issues at the time of manufacturing of this device and its sub components that would contribute to the complaint condition.The raw material certificate was reviewed, and the used material was according to the specification of the device.No ncrs were generated during the production of this device.Investigation conclusion: the complaint condition is confirmed.While no definitive root cause could be determined, it is possible that the device encountered unintended forces (during usage or handling at the time of surgery).During the investigation, no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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: BONE SPREADER 7MM BEAK WIDTH
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8388483
• Report Number: 2939274-2019-56792
• Device Sequence Number: 19390028
• Product Code: LXH
• UDI-Device Identifier: 10886982201980
• UDI-Public: (01)10886982201980
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2019

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: 398.93
• Device Lot Number: T149123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1