MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI LCP(TM) CLAVICLE HOOK PL 5H RT-18MM HOOK DEPTH-STER; PLATE, FIXATION, BONE

Catalog Number 441.086S

Device Problem Migration (4003)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event is an unknown date in 2018.Complainant part is not expected to be returned for manufacturer review/investigation.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.A device history record review has been requested.(b)(4).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 (b)(6) reports an event as follows: it was reported that the patient presented the hospital on (b)(6) 2018, due to pain in the shoulder.The patient could not lift the shoulder at that time.X-rays were taken, and it was found that the tip of the lcp clavicle hook plate had protruded from the acromion.The surgeon commented about the contributing factors since the affected site was on the side of paralysis; the bone quality was not good.The patient originally had an open reduction internal fixation with a locking compression plate (lcp) clavicle hook plate on (b)(6) 2018, for a distal clavicle fracture.Postoperative x-rays confirmed that the hook of the plate was properly located under the acromion.Surgery to remove the plate has been scheduled on (b)(6) 2019.If union has started at that time, conservative treatment and follow up observation will be performed after the re-operation.The patient is visiting the hospital on a regular basis and still has strong pain in the shoulder.This report is for a 3.5mm titanium (ti) lcp(tm) clavicle hook plate.This is report 1 of 2 for (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.Device history lot part: 441.086s.Lot: l664786.Manufacturing site: raron.Release to warehouse date: 11.Dec.2017.Expiry date: 01.Dec.2027.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.However, alternative equipment has no negative influence on product quality at all.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.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: 3.5MM TI LCP(TM) CLAVICLE HOOK PL 5H RT-18MM HOOK DEPTH-STER
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8200386
• MDR Text Key: 131532787
• Report Number: 8030965-2018-59278
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819803558
• UDI-Public: (01)07611819803558
• Combination Product (y/n): N
• PMA/PMN Number: K061753
• 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: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 441.086S
• Device Lot Number: L664786
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR