MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SMALL UNIVERSAL CHUCK WITH T-HANDLE; MISC ORTHO SURGICAL INSTR

Catalog Number	393.105
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Is no patient involvement.Date of event is unknown.Device is an instrument and is not implanted/explanted.Reporter email address is unavailable.Reporter is a synthes employee.Part: 393.105; lot: l654443; manufacturing site: (b)(4); release to warehouse date: december 20, 2017 the device history record shows this lot 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.Only top level of the device history record reviewed as sub-components are not lot tracked.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Customer quality investigation: investigation flow: damage- visual (appearance not as expected): visual inspection: the returned instrument was examined, and the device was found to be damaged and slightly deformed at its jaws, there are impact marks across the entire device.The teeth are stuck in the closed position.The balance of the device is in fair condition.The received condition does not agree with the reported broken complaint description.However, with the deformation and stuck condition identified, the overall complaint condition was confirmed.Document/specification review: design drawing from date of manufacture to current were reviewed during this investigation and no design issues were identified.Top-level drawing: due to the post manufacturing damage observed, the dimensional analysis on relevant portions were not performed.The device history record showed that this lot 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.Therefore, review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Conclusion: the complaint condition of broken was not confirmed as there is no indication of breakage, however there is evidence of damage and device jamming.A root cause could not be determined as the circumstances surrounding the complaint are unknown.However, it is possible that unintended forces on the device during usage could have led to internal damage which in turn led to observed stuck complaint condition.During the investigation, no product design or manufacturing issues 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.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 inbound inspection of the returned loaner kit on (b)(6) 2018, it was observed that the small universal chuck with t-handle was broken.The chuck has been removed from the set, placed in quarantine and will be returned for evaluation.There was no patient or hospital involvement.This report is for a small universal chuck with t-handle.This is report 1 of 1 for (b)(4).

• Brand Name: SMALL UNIVERSAL CHUCK WITH T-HANDLE
• 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: 7891087
• Report Number: 2939274-2018-53855
• Device Sequence Number: 1928029
• Product Code: LXH
• UDI-Device Identifier: 10886982199034
• UDI-Public: (01)10886982199034
• 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
• Report Date (Section B): 07/30/2018

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: 393.105
• Device Lot Number: L654443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1