MAUDE Adverse Event Report: SYNTHES GMBH 135 DEG LCP DHS PLATE-STANDARD BARREL 4 HOLES/92MM-STERILE; PLATE, FIXATION, BONE

Catalog Number 02.224.224S

Device Problem Device-Device Incompatibility (2919)

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Device is not distributed in the united states, but is similar to device marketed in the usa.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that during a procedure on an unknown date in 2021 the locking compression (lcp) dynamic hip system (dhs) plate did not fit to the lcp dhs screw as it should.The procedure was completed successfully with no delay.No further information provided.This report is for one (1) 135 deg lcp dhs plate-standard barrel 4 holes/92mm-sterile this is report 1 of 1 for complaint (b)(4).

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.H3, h6: a product investigation was conducted.Visual inspection: the lcp dhs-pl 135° 4ho l92 standbarrel sst (part #: 02.224.224s, lot #: 138p134) was received at us cq.Visual inspection of the complaint device showed no damage or defect.Functional test: a functional assessment could not be performed as the device was returned by itself.Dimensional inspection: dimensional inspection cannot be performed as the complaint relevant dimensions could not be taken.Document/specification review: based on the date of manufacture, the current and manufactured revision documents were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is not confirmed as there was no defect observed from the visual inspection of the returned plate.No root cause could definitively be determined for the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.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 preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H3, h4, h6: a device history record (dhr) review was conducted: product code: 02.224.224s, lot number: 138p134, manufacturing site: grenchen, release to warehouse date: 29 april 2021, expiry date: 01 may 2031.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was 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.

• Brand Name: 135 DEG LCP DHS PLATE-STANDARD BARREL 4 HOLES/92MM-STERILE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12371180
• MDR Text Key: 268263411
• Report Number: 8030965-2021-07227
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819821217
• UDI-Public: (01)07611819821217
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/16/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 02.224.224S
• Device Lot Number: 138P134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 09/01/2021
• Supplement Dates FDA Received: 09/30/2021
• Patient Sequence Number: 1
• Treatment: LCP DHS SCREW; LCP DHS SCREW