MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HAMMER GUIDE FOR TI ELASTIC NAILS; HAMMER, SURGICAL

Catalog Number	359.218
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.A product investigation was conducted.Visual inspection: the complaint device hammer guide f/ten (product code: (b)(4), lot number: unk) was returned to cq west chester for investigation.The hammer guide distal end had broken and the broken piece was not returned for investigation.The device also had impaction marks on its head and was severely deformed.Document /specification review: the date of manufacture for the item was not available, hence the current revision of drawing was reviewed.Dimensional inspection: complaint relevant dimension cannot be measured due to post manufacturing damage to the distal end.Conclusion: the hammer guide was broken and had a severe damage consistent with field usage.A definitive root cause was not determined during investigation.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.Lot number of the item was not available for 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
Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that during a procedure on (b)(6) 2021, the thread of the hammer guide was stripped.No further information provided.During manufacturer's investigation of the returned device it was also identified that the hammer guide distal end had broken and the broken piece was not returned for investigation.This device condition was evaluated and determined to be reportable on (b)(6) 2022.This report is for one (1) hammer guide for ti elastic nails this is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.A product investigation was conducted.Visual inspection: the complaint device hammer guide f/ten (product code: (b)(4), lot number: unk) was returned to cq west chester for investigation.The hammer guide distal end had broken and the broken piece was not returned for investigation.The device also had impaction marks on its head and was severely deformed.Document /specification review: the date of manufacture for the item was not available, hence the current revision of drawing was reviewed.Dimensional inspection: complaint relevant dimension cannot be measured due to post manufacturing damage to the distal end.Conclusion: the hammer guide was broken and had a severe damage consistent with field usage.A definitive root cause was not determined during investigation.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.Lot number of the item was not available for 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
Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that during a procedure on (b)(6) 2021, the thread of the hammer guide was stripped.No further information provided.During manufacturer's investigation of the returned device it was also identified that the hammer guide distal end had broken and the broken piece was not returned for investigation.This device condition was evaluated and determined to be reportable on (b)(6) 2022.This report is for one (1) hammer guide for ti elastic nails this is report 1 of 1 for complaint (b)(4).

• Brand Name: HAMMER GUIDE FOR TI ELASTIC NAILS
• Common Device Name: HAMMER, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BALSTHAL (CH); dornacherstrasse 20; balsthal 4710 ; SZ 4710
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13416362
• Report Number: 2939274-2022-00309
• Device Sequence Number: 4870758
• Product Code: FZY
• UDI-Device Identifier: 07611819104365
• UDI-Public: (01)07611819104365
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 359.218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown