MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREW AND PLATE HOLDING FORCEPS

Model Number	347.985
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.Part number: 347.985, lot number: a7pa23, manufacturing site: (b)(4), release to warehouse date: week 23, 2006.A review of the device history records is not possible, the dhr is no longer available due to the age of the instrument (over 14 years old).Visual inspection: the screw and plate holding forceps (part # 347.985/ lot # a7pa23) was received at us customer quality (cq).Upon visual inspection it was noticed that one of the forcep was broken at the tip.No other defects were identified on the device.Device failure/defect identified? yes; broken tip was identified.Dimensional inspection: dimensional inspection was not performed due to post-manufacturing damage.Conclusion: the overall complaint was confirmed for the received screw and plate holding forceps as the tip was broken.Although no definitive root-cause can be determined it¿s possible the device experienced unintended forces.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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, during routine incoming inspection of a loaner set at the field service location, it was observed that the screw and plate holding forceps was broken.There was no known patient or hospital involvement.This report involves one (1) screw and plate holding forceps.This is report 1 of 1 for (b)(4).

• Brand Name: SCREW AND PLATE HOLDING FORCEPS
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11399063
• Report Number: 2939274-2021-01120
• Device Sequence Number: 1166616
• Product Code: HTD
• UDI-Device Identifier: 10886982193629
• UDI-Public: (01)10886982193629
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/08/2021

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: 347.985
• Device Catalogue Number: 347.985
• Device Lot Number: A7PA23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1