MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 13.0MM CANNULATED DRILL BIT 300MM; INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH

Catalog Number	351.27
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
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.Reporter is synthes sales consultant.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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, it was noted that the cannulated drill bit opening reamer broke.There was no patient involvement.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.A device history record (dhr) review was conducted for part number: 351.27, synthes lot number: u238844, supplier lot number: n/a: release to warehouse date: 12-may-2016, expiration date: n/a, supplier: (b)(4.Nonconformance report (ncr) was generated during production for 9 of (b)(4) parts with a torn package (hole).9 parts were returned to vendor and (b)(4) parts were released from hold.This non-conformance is not relevant to the complaint condition since it is not related to broken cannulated drill bit opening reamer.The material was reviewed, and the hardness value was confirmed to meet the specification with no (relevant) non-conformance noted.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.A product investigation was conducted.The following investigations were performed: broken: device condition: visual inspection performed at customer quality (cq) observed broken at its shaft portion proximal to its connection end.Broken portions were not returned.No new issues other than minor worn surfaces that would not affect the product functionality were observed.The given device condition agrees with the complaint description and therefore the complaint condition was able to be confirmed.Dimensional analysis and document/specification review: relevant drawings for the returned instrument were reviewed (both from the time of manufacture and present revision) and no design issues were noted.Dimensional analysis performed on the remnant portions of the broken shaft measured and it falls within the specification per relevant drawing.Review of the device history record showed an ncr that was generated to address the torn package (holes on 9/(b)(4) parts).The packages with confirming packaging were only released and therefore no ncr were observed on the released parts.Furthermore, the ncr noted on packaging is irrelevant to the given broken condition of the device.Therefore, based off the dhr review it was confirmed that no issues were identified that would contribute to complaint condition.Furthermore, the material review performed during dhr showed no issues with the material and its properties that could have contributed to complaint condition.No definitive root cause was able to be determined.However, any unintended excessive forces encountered during usage with possible off-axis using could have led to this complaint condition.Conclusion: this complaint is confirmed; however, no product design issues or manufacturing discrepancies were identified during 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.
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: lot number is now known.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A device history record review has been requested.Date of manufacture is now known.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: 13.0MM CANNULATED DRILL BIT 300MM
• Common Device Name: INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7748795
• Report Number: 2939274-2018-53189
• Device Sequence Number: 1560471
• Product Code: HWE
• UDI-Device Identifier: 10886982193797
• UDI-Public: (01)10886982193797
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2018

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 Catalogue Number: 351.27
• Device Lot Number: U238844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 09/13/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 08/28/2018; 09/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1