MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ALUMINUM HOHMANN RETRACTOR 24MM WIDTH

Model Number	03.100.110
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 (b)(6) 2020, during total shoulder resurfacing surgery, the aluminum hohmann retractor 24mm width broke, and the tip was lodged in the patient's right proximal humerus.The surgeon attempted to retrieve it multiple times under fluoroscopy.The surgeon decided to leave the stainless-steel broken tip in place to maintain the integrity of the humerus.The surgery completed as planned with no additional interventions.The patient was informed.It is unknown if there was a surgical delay.The procedure outcome is unknown.The patient is doing well with a full range of motion.This report involves one (1) aluminum hohmann retractor 24mm width.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint #(b)(4).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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative.D10: concomitant device reported.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.H3, h4, h6: device history lot.Part number:03.100.110.Synthes lot number: 6718770.Supplier lot number: n/a.Release to warehouse date: 29aug2011.Expiration date: n/a.Supplier: greatbatch medical.No ncrs were generated during production.Device history batch null, device history review 04-feb-2021: dhr reviewed.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that 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.

• Brand Name: ALUMINUM HOHMANN RETRACTOR 24MM WIDTH
• Common Device Name: RETRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11333693
• Report Number: 2939274-2021-00886
• Device Sequence Number: 10968638
• Product Code: GAD
• UDI-Device Identifier: 10886982071088
• UDI-Public: (01)10886982071088
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.100.110
• Device Catalogue Number: 03.100.110
• Device Lot Number: 6718770
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALUMINUM HOHMANN RETRACTOR 24MM WIDTH.
• Outcome Attributed to Adverse Event: Required Intervention