MAUDE Adverse Event Report: SYNTHES GMBH PELVIC OSTEOTOME 20MM/304MM

Catalog Number	399.860
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
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.E1 initial reporter facility address: (b)(6).E3: reporter is a j&j employee.H3, h4, h6 investigation summary: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device revealed that the device was originally a j&j product but was refurbished and possibly modified by a different company (instrumenta ab), as they have added their etch onto the impacted product.One of the handle pins is identified to be missing, and the tip of the device was stripped.However it is unclear if that happened before or after the refurbishment/modification by instrumenta ab.Due to the modification, this complaint will be communicated to brand protection.The complaint condition is confirmed as the pin is missing and the tip is stripped, but cannot be traced to a factor within jnj control, due to the refurbishment/modification by a third party company.Device history review (dhr): part number: 399.860 lot number: 747p202 manufacturing site: tuttlingen release to warehouse date: 02-may-2022 a review of the device history records was performed for the finished device lot number, and no non-conformances were identified.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 18 march 2024, the customer called regarding a chisel with a blue plastic handle on top of the metal handle.The plastic is printed with two metal plugs, one of which is gone and the other is on its way out.Another nurse also mentioned that the chisel was dull.There was no patient involvement.There was no surgical delay.Upon evaluation of the device on 5-june-2024, it was noted that the device was stripped, and was also refurbished and possibly modified by a third party company.This report involves one pelvic osteotome 20mm/304mm.This is report 1 of 1 for (b)(4).

• Brand Name: PELVIC OSTEOTOME 20MM/304MM
• Common Device Name: OSTEOTOME
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19498240
• Report Number: 8030965-2024-07257
• Device Sequence Number: 20517046
• Product Code: HWM
• UDI-Device Identifier: 10886982203120
• UDI-Public: (01)10886982203120
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: 399.860
• Device Lot Number: 747P202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown