MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM LCP PROXIMAL FEMUR HOOK PLATE 16 HOLES/385MM; PLATE, FIXATION, BONE

Catalog Number 242.127

Device Problem Material Integrity Problem (2978)

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: reporter is (b)(6).Photo investigation summary: a photo investigation was performed based on the images provided.The image was reviewed, and the complaint condition can be confirmed since the visible features of the device are damaged and deformed.A definitive assignable root cause could not be determined based on the provided information.The subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 france as follows: it was reported that upon receipt of the device from customer it was noted that the device is damaged.There was no known patient involvement.During manufacturer's investigation of the provided image it was identified that the visible features of the device are damaged and deformed.This report is for one (1) 4.5 mm lcp proximal femur hook plate 16 holes/385mm.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: g1.Manufacturing site name and address.H4.Device manufacture date.H6 - codes updated to imdrf codes.Investigation summary: the complaint device lcp proxfem hookpl 4.5/5 shaft 16ho l385 (product code: 242.127, lot number: unk) was not received for investigation.A photo investigation was performed based on the images attached to file: "(b)(4) picture-img_4090".The image was reviewed, and the complaint condition can be confirmed since the visible features of the device are damaged and deformed.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Background: the device is damaged visual inspection: the complaint device lcp proximal femur hook plate (product code: 242.127, lot number: h214440) was returned to cq west chester for investigation.The hook opening on the plate was deformed due to severe damage.The holes on the plate had multiple deep scratches and nicks.Document /specification review: based on the date of manufacture, the current and manufactured version of the drawings were reviewed.Dimensional inspection: complaint relevant dimension could not be measured due to the geometry of the device.Conclusion: the hook plate was deformed and damaged.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.Device history lot - a manufacturing records evaluation (mre) was not performed.A manufacturing record evaluation was performed for the finished article lot 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.

• Brand Name: 4.5MM LCP PROXIMAL FEMUR HOOK PLATE 16 HOLES/385MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach NY 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13228061
• MDR Text Key: 285457299
• Report Number: 8030965-2022-00240
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819910010
• UDI-Public: (01)07611819910010
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K032032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 242.127
• Device Lot Number: H214440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 01/11/2022
• Supplement Dates Manufacturer Received: 02/01/2022
• Supplement Dates FDA Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/19/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1