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

Model Number	03.100.114
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device deemed reportable at conclusion of investigation on (b)(6) 2020.Investigation summary: visual inspection: the aluminum hohmann retractor 8mm short narrow tip (product code: 03.100.114 & lot no: h891720) was received at us cq.The visual inspection of the received device indicated a deep cut on the distal end near the narrow tip and it appears like a saw blade cut a visual horizontal crack was observed on the opposite side of the cut location near the distal tip.Thus the complaint was confirmed.The attached photos did not add any new information upon review.Device failure/defect identified? yes.Dimensional inspection: the dimensional inspection was not performed due to the post-manufacturing damage.Document/specification review: the following drawing reflecting current and manufactured revision was reviewed: small hohmann retractor 8 mm short narrow tip 220 mm aluminum.Complaint confirmed? yes.The device distal tip was damaged.Investigation conclusion: the complaint condition was confirmed for the received device as the device distal tip was damaged.While no definitive root cause could be determined based on the provided information, it is possible that the user cut the device unintendedly during use.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 history: part number: 03.100.114, synthes lot number: h891720, supplier lot number: n/a, release to warehouse date: 12jun2020, expiration date: n/a, supplier: (b)(4).No ncrs were generated during production.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.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 on (b)(6) 2020, a set was opened at sterile processing department (spd) to fill in back-ordered items that came in.It was noticed that an aluminum hohmann retractor was damaged.There was no patient involvement.During investigation, it was determined the device was broken/cracked.This is report 1 of 1 for (b)(4).

• Brand Name: ALUMINUM HOHMANN RETRACTOR 8MM SHORT NARROW TIP
• Common Device Name: RETRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10648158
• Report Number: 2939274-2020-04571
• Device Sequence Number: 2727938
• Product Code: GAD
• UDI-Device Identifier: 10886982071118
• UDI-Public: (01)10886982071118
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 09/08/2020

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: 03.100.114
• Device Catalogue Number: 03.100.114
• Device Lot Number: H891720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1