MAUDE Adverse Event Report: SYNTHES GMBH ADAPT Ø2.8 F/LCP PAED-HIP PL3.5/5.0; ORTHOPAEDIC IMPLANT/INSTRUMENT ADAPTOR, REUSABLE

Catalog Number 03.108.040

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2022

Event Type  malfunction  

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.Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The lot number was unknown.Therefore, the expiration date and device manufacture date were unknown.Without a lot number the device history records review could not be completed.Product was not returned.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 Description

Device report from depuy synthes reports an event in australia as follows: this is report 3 of 5 for (b)(4).It was reported by the sales rep in australia that during an unknown surgery on (b)(6)2022, it was observed that two k-wire devices jammed in each guide (03.108.001 and 03.108.002) and the plate device was used as a guide instead.It was further reported that during removal of wires later, the extender also appeared damaged.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.This report is for one (1) adapt ø2.8 f/lcp paed-hip pl3.5/5.0device.This complaint involves five (5) devices.

• Brand Name: ADAPT Ø2.8 F/LCP PAED-HIP PL3.5/5.0
• Type of Device: ORTHOPAEDIC IMPLANT/INSTRUMENT ADAPTOR, REUSABLE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14196556
• MDR Text Key: 298471097
• Report Number: 8030965-2022-02676
• Device Sequence Number: 1
• Product Code: HXS
• UDI-Device Identifier: 07611819420939
• UDI-Public: 07611819420939
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.108.040
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1