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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH LOCKSCR Ø3.5 SELF-TAP L28 TAN ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH LOCKSCR Ø3.5 SELF-TAP L28 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 412.110S
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/23/2019
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: the returned locking screw head was forwarded to the manufacturing side for evaluation. The statement below is a summary of their investigation. As received condition, 6 screws have been returned (only the head screw was returned) unpacked and outside the original depuy synthes bag. The 6 broken screws correspond to the (b)(4). The screw is broken at the neck point and have strong traces of use on its surface. The laser mark is present and readable. The lot number on the complaint received corresponds to the lot number on the complaint part. The received condition of the article agrees with the complaint description since the screw is broken as claimed by the customer. Besides, the complaint is confirmed, since the available data supports the complainant¿s description of the complaint condition. However, from the manufacturing point of view, neither a defect nor a deficiency has been identified since no deviations were found in the documentation as well as during this investigation all relevant measurements performed are according to its specifications. Since no manufacturing issue was detected, no further actions have been taken. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Device history lot : part: 412. 110s, lot: l896160, manufacturing site: grenchen, release to warehouse date: 23. May 2018, expiry date: 01. May 2028. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified. 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 that on (b)(6) 2018, the patient underwent internal fixation surgery with the plate and the 6 locking screws in question. On (b)(6) 2019, the patient underwent removal surgery. During the removal surgery, the 6 locking screws broke at those necks. The surgeon removed the plate, but he didn¿t remove the 6 screw shafts, and he finished the surgery. The 6 screw shafts remained in the body. No further information is available. Concomitant devices reported: unknown plates: tibia (part# unknown, lot# unknown, quantity# 1) lcp med prox-tibpl 3. 5 le shaft 6ho l119 (part# 439. 957s, lot# h582399, quantity# 1). This complaint involves six (6) devices. This is 1 of 6 for report (b)(4).
 
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Brand NameLOCKSCR Ø3.5 SELF-TAP L28 TAN
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK GRENCHEN (CH)
solothurnstrasse 186
grenchen 2540
SZ 2540
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key9350060
MDR Text Key191250309
Report Number8030965-2019-70391
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number412.110S
Device Lot NumberL896160
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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