MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SMALL HOHMANN RETRACTOR 8MM SHORT NARROW TIP 160MM

Model Number	399.19
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is a company representative.Device manufacture date: 50th week of 1999.Investigation summary: part number: 399.19, lot number: a7ia50, manufacturing site: (b)(4), release to warehouse date: week 50, 1999.A review of the device history records is not possible, the dhr is no longer available due to the age of the instrument (over 19 years old).Visual inspection: small hohmann retractor 8mm short narrow tip 160mm was received at customer quality (cq).Upon visual inspection, the retractor was found to broken at the tip.The broken tip was not received at us cq.Thus, the complaint is confirmed.The rest of the device shows normal wear which would not contribute to the complaint condition.Device failure/ defect found? yes.Dimensional inspection: dimensional inspection of the device at the tip cannot be performed due to the post manufacturing damage.And the device was almost 20 years old.Thus, the dimensional or design issue might have not contributed to the complaint condition.Document/ specification review: respective drawings were reviewed during the investigation.No design issues or discrepancies were noted during the investigation.Complaint confirmed? yes.Investigation conclusion: visual inspection of the returned device, and document/ specification review were performed at cq.The reported condition of broken tip of the device is confirmed.A definitive root cause for the post manufacturing damage could not be determined, it is possible that the device might have encountered unintended forces.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified during this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 on an unknown date, during a routine incoming inspection of a loaner set, a small hohmann retractor was observed broken.There were no patient nor procedure involvement.This complaint involves one (1) device.This report is for one (1) small hohmann retractor 8mm short narrow tip 160mm.This is report 1 of 1 for (b)(4).

• Brand Name: SMALL HOHMANN RETRACTOR 8MM SHORT NARROW TIP 160MM
• Common Device Name: RETRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9153291
• Report Number: 2939274-2019-61112
• Device Sequence Number: 2694040
• Product Code: GAD
• UDI-Device Identifier: 10886982202512
• UDI-Public: (01)10886982202512
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 09/09/2019

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: 399.19
• Device Catalogue Number: 399.19
• Device Lot Number: A7IA50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1