MAUDE Adverse Event Report: EIT EMERGING IMPLANT TECHNOLOGIES GMBH SLAP-HAMMER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	PET60251
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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: h3, h6: part: pet60251.Lot: e20di0569.Supplier: (b)(4).Batch1: released on 05 march 2021 with no discrepancies.No nonconformance reports (ncrs) were generated during production.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.¿ visual analysis of the returned device found the laser weld near the interface and the rod was broken, fragments still attached.A root cause for this condition cannot be established.With the information provided we cannot confirmed that the device has been received in the condition it was found.A dimensional inspection was not performed due to post manufacturing damage.The overall complaint was unconfirmed as the observed condition of the slap-hammer would not contribute to the complained device issue.¿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.¿ as part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.¿ drawing/specifications reviewed current and manufactured revision were reviewed.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 february 7, 2024, the customer reported that the lsy expedium viper loaner orthokit set came with one of the ejectors defective.There was no patient involvement.Upon manufacturer investigation, it was determined that the laser weld near the interface and the rod was broken; fragments still attached.This report is for a slap-hammer.This is report 1 of 1 for (b)(4).

• Brand Name: SLAP-HAMMER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; eisenbahnstrasse 84; wurmlingen D-785 73; DE D-78573
• Manufacturer Contact: daniel sopanha seng ; eisenbahnstrasse 84; wurmlingen ; GM ; 7461716905
• MDR Report Key: 19153181
• Report Number: 3013730328-2024-00048
• Device Sequence Number: 18254088
• Product Code: LXH
• UDI-Device Identifier: 04260397088081
• UDI-Public: (01)04260397088081
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K172888
• 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: PET60251
• Device Lot Number: E2DI0569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2021
• 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