MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 28MM; NAIL,FIXATION,BONE

Catalog Number 212.110

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Patient¿s date of birth/age and weight are unknown.This report is for one (1) unknown screw.The reported screws are: 212.114, 212.117, 212.110; however, it is unknown which screw broke from the reported screws.Without the specific part and lot number, the udi is not available.Device broke during insertion; device not considered implanted/explanted.Complainant device is not expected to be returned for manufacturer review/investigation.Reporter phone number is not provided for reporting.510k): unknown.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 europe reports an event in (b)(6) as follows: it was reported that a screw broke during a procedure and part of it remained in the patient's bone.There is no additional information.Concomitant device reported: 3.5mm lcp® proximal humerus plate-standard 3h shaft/90mm (part # 241.901, lot # l188727, quantity 1).This report is for one (1) unknown screw.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

(b)(4).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

It was reported patient was implanted with a 3.5mm locking compression plate (lcp) proximal humerus plate-standard 3 hole shaft 90mm plate and unknown quantity of screws for pseudoarthrosis of proximal humerus on unknown date in (b)(6) 2017.In (b)(6) 2017 it was noted that one of the 3.5mm locking screws was broken, resulting in displacement of the pseudoarthrosis.Patient was returned to surgery on (b)(6) 2017 for hardware removal.Concomitant devices reported: 3.5mm locking compression plate (lcp) proximal humerus plate-standard 3 hole shaft 90mm plate (241.901, lot l188727, quantity 1), 3.5mm locking screw self tapping with stardrive recess 28mm (212.110, lot number unknown, quantity 4), 3.5mm locking screw self tapping with stardrive recess 40mm (212.117, lot number unknown, quantity 2), 3.5mm locking screw self tapping with stardrive recess 35mm (212.114, lot number unknown, quantity 1), 3.5mm cortex screw 24mm (204.024, lot number unknown, quantity 1), 3.5mm cortex screw 26mm (204.026, lot number unknown, quantity 1).

Manufacturer Narrative

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.

Manufacturer Narrative

Additional narrative: device history records review was completed for part# 212.110, lot# 9097800.Manufacturing location: (b)(4), release to warehouse date: aug 11, 2014.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product development investigation was completed.The returned broken screw was confirmed as being broken in the point between the shaft and the screw head.Only the screw head was returned as the shaft remained in the patient¿s bone.The screw head has been returned not in original packaging together with a plate and other 9 screws.Among these 9 screws there was one form the same lot of the complained item (lot 9097800).Due to the facts that the screw broke post production, it was not possible to measure the broken screw.The other screw of the same lot 9097800 returned was investigated (screw b).This screw has been produced with the same condition (raw material, cnc program, tools).The part was inspected for all the features pertinent to the complaint conditions.The thread of the screw b is damaged post production but all the measurable features of the screw b pertinent to complaint condition have been found conforming to specification.It was reported that the subject patient was a smoker with osteoporosis, which could have contributed to the complaint condition.Considering that all relevant product features of the measurable screw of the involved lot meet specification and no visual defects and nonconformance manufacturing related have been identified on returned items, the conclusion of the product investigation is that the returned parts are conforming from a manufacturing perspective.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.

Manufacturer Narrative

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 LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 28MM
• Type of Device: NAIL,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7131549
• MDR Text Key: 95962225
• Report Number: 8030965-2017-50854
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K072095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 212.110
• Device Lot Number: 9097800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 01/11/2018; 02/15/2018; 02/21/2018; 02/22/2018
• Supplement Dates FDA Received: 01/25/2018; 02/15/2018; 02/21/2018; 02/22/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 55